Recontacting Subjects in Genetic Research

The statute and rules also addresses recontact of research subjects. The statute prohibits recontact of a subject based on coded information. The rule requires the subject be notified of the specific circumstances under which recontact can occur in the original consent process. Any recontact option, whether part of the original protocol or a later application, must be approved by the IRB. However, if recontact was not contemplated during the original consent process, the researcher must seek separate IRB approval for recontact. The threshold for permissible recontact is extremely high. Such approval must assure three conditions: that the findings are scientifically valid and confirmed (e.g., the DNA was analyzed by a CLIA approved facility); that they have significant implications for the subject’s or public’s health, AND that a course of action to ameliorate or treat the subject’s or the public’s health concerns be readily available. Additionally, the researcher is required to determine and adhere to the expressed wishes and desires of the research subject in relation to disclosure of genetic information to that individual. Finally, if research results are disclosed to a subject, appropriate medical advice and referral must be provided (OAR 333-025-0130).